News

NIH Develops Novel Tumor Identification Technology

June 26, 2023

The Segmentation by Exogenous Perfusion system uses a cell’s location in the tumor to find differences in gene activity.

FDA Releases Psychedelic Drugs Draft Guidance

June 26, 2023

FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.

Sanofi Consumer Healthcare Opens Suggestion Portal

June 23, 2023

Sanofi’s Open Innovation Portal is designed to promote community feedback and propose novel solutions to various problems in the healthcare landscape.

Aenova Opens New Building for Highly Potent Drugs

June 23, 2023

Aenova has opened a new building for the production of highly potent APIs in Germany.

SandboxAQ Launches Molecular Simulation Division

June 23, 2023

Sandbox AQ’s molecular simulation division is collaborating with companies like AstraZeneca and Sanofi to develop novel treatments for various disorders.

FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act

June 23, 2023

The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

Andelyn Biosciences Opens New CGT Manufacturing Headquarters

June 22, 2023

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

FDA Releases Updated COVID-19 Vaccine Guidelines

June 21, 2023

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk

June 21, 2023

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

Saudi Arabia’ PIF Launches Lifera, a New CDMO

June 21, 2023

PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.